The Rate of Kidney Transplants in Sensitized Patients.NCT01896089
Regional Kidney Paired Donor Exchange in Sensitized Patients
An observational study of The Rate of Kidney Transplants in Sensitized Patients., run by BiologicTx, LLC at 2 sites in United States.
Trial summary
This is a prospective, multi-center, observational study to determine if a combination of desensitization and enrollment in a regional kidney paired donor (KPD) exchange program improves the overall rate of kidney transplantation in sensitized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Rate of Kidney Transplants in Sensitized Patients.
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Dec 2018
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 250 renal transplant candidates at 6 transplantation centers in the United States (northwest) will participate.
Who may be able to join
- A. Potential Recipients must meet the following inclusion criteria:
- Willing and able to sign an informed consent form
- Must be at least 18 years old
- Meet all recipient selection criteria of the transplant center
- Listed on the deceased donor kidney waiting list for renal transplant at a participating center
- Potential recipients must:
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- Group 1: have one or more medically suitable donors who are ABO incompatible or HLA incompatible (defined as positive serologic cross-match); or
- Group 2: have a medically suitable donor that is otherwise deemed incompatible due to age, size, or other mismatch by their respective transplant center; or
- Group 3: be listed on the deceased donor waiting list for ≥ one year without an identifiable living donor and have a PRA% ≥ 60%
- Potential Living Donors must meet the following inclusion criteria:
- Must provide informed consent in accordance with the process outlined in the Informed Consent Requirements Section of the KPD Program Manual of Operations
- Must be at least 18 years old
- Meet all living donor selection criteria of the transplant center
- Meet the evaluation requirements set forth in the Living Donor Evaluation Section of the KPD Program Operational Guidelines
Who cannot join
- C. Recipients
- Do not meet selection criteria of the transplant center
- Eligible compatible donor at the time of enrollment
- Inactive (not eligible to receive a kidney) on the deceased donor waitlist
- Pregnant or breast feeding
- Donors
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- Unwilling or unable to provide informed consent
- Have identified barriers to donation as set forth in the Living Donor Evaluation Section of the KPD Program Manual of Operations (Appendix A)
- Must not be currently listed as a potential living donor for any other recipient registered in the KPD system
- Pregnant or breast feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
Donald Rodriguez, 206-342-6958, donald.rodriguez@vmmc.org
Andrew Weiss, MD
- Recruiting
Swedish Medical Center
Seattle, Washington, 98104
Terri Spinelli, 206-215-3063, terri.spinelli@swedish.org
Lisa Florence, MD
About this study
Official title: Prospective, Multicenter, Observational Registry Study to Determine if Enrollment in a Regional Kidney Paired Donor Exchange Program Improves the Overall Rate of Kidney Transplantation in Sensitized Patients, and Sensitized Patients Undergoing Desensitization Treatments.
This is a prospective, multi-center, observational study to determine if a combination of desensitization and enrollment in a regional kidney paired donor (KPD) exchange program improves the overall rate of kidney transplantation in sensitized patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program will be summarized.
Measured: 24 months
Secondary outcomes (1)
Overall number of kidney transplants per center/region
To determine the overall number of kidney transplants per center/region.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Rate of Kidney Transplants in Sensitized Patients.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- BiologicTx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Florence, MD, Principal investigator, Swedish Medical CenterAndrew Weiss, MD, Principal investigator, Virginia Mason Medical CenterDouglas Norman, MD, Principal investigator, Oregon Health and Science UniversityRichard Carson, MD, Principal investigator, Sacred Heart Medical Center (Spokane)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896089
- Sponsor's protocol ID
- KPD6172013
- Status last verified
- Aug 2016
- First submitted
- 28 Jun 2013
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Observational Registry Study to Determine if Enrollment in a Regional Kidney Paired Donor Exchange Program Improves the Overall Rate of Kidney Transplantation in Sensitized Patients, and Sensitized Patients Undergoing Desensitization Treatments.
- ClinicalTrials.gov ID
- NCT01896089
- Acronym / sponsor ID
- KPD6172013
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BiologicTx, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2018 (estimated)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, observational study to determine if a combination of desensitization and enrollment in a regional kidney paired donor (KPD) exchange program improves the overall rate of kidney transplantation in sensitized patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 250 renal transplant candidates at 6 transplantation centers in the United States (northwest) will participate.
Key inclusion criteria (14 listed)
- A. Potential Recipients must meet the following inclusion criteria:
- Group 1: have one or more medically suitable donors who are ABO incompatible or HLA incompatible (defined as positive serologic cross-match); or
- Group 2: have a medically suitable donor that is otherwise deemed incompatible due to age, size, or other mismatch by their respective transplant center; or
- Group 3: be listed on the deceased donor waiting list for ≥ one year without an identifiable living donor and have a PRA% ≥ 60%
- Potential Living Donors must meet the following inclusion criteria:
Key exclusion criteria (10 listed)
- C. Recipients
- Donors
- Unwilling or unable to provide informed consent
- Have identified barriers to donation as set forth in the Living Donor Evaluation Section of the KPD Program Manual of Operations (Appendix A)
- Must not be currently listed as a potential living donor for any other recipient registered in the KPD system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program
Time frame: 24 months
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program will be summarized.
1 secondary outcome
Overall number of kidney transplants per center/region
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Florence, MD principal investigator
Swedish Medical Center
Andrew Weiss, MD principal investigator
Virginia Mason Medical Center
Douglas Norman, MD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Rate of Kidney Transplants in Sensitized Patients., run by BiologicTx, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.